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April 2, 2012News for the biotech, medical device, drug and food regulatory profession

  Drugs & Biologics 
  • Bayer's anti-coagulant Xarelto gets NICE endorsement
    The U.K. National Institute for Health and Clinical Excellence recommended Xarelto as preventive therapy for systemic embolism and stroke in patients with atrial fibrillation, after maker Bayer submitted additional information on the anti-coagulant. Xarelto competes with Boehringer Ingelheim's Pradaxa, which gained NICE endorsement in November. Fox Business/Dow Jones Newswires (3/29) Email this Story
  Food & Dietary Supplements 
  • FDA rejects petition to ban BPA in food packaging
    The FDA on Friday rejected the Natural Resources Defense Council's petition to ban the use of bisphenol A in food packaging on grounds that the group failed to give sufficient scientific evidence to revise the current regulations. However, FDA spokesman Douglas Karas said "this is not a final safety determination on BPA." Los Angeles Times/Booster Shots blog (tiered subscription model) (3/30), Reuters (3/30) Email this Story
  Featured Content 
 

  Medical Devices 
  • Senators want stronger FDA oversight after GAO report
    The findings of a Government Accountability Office report presented during a Senate hearing on the proposed medical device user fee agreement prompted Sens. Richard Burr, R-N.C., and Tom Coburn, R-Okla., to call for tougher oversight of the FDA. The report indicated that medical device review times have risen significantly. The Hill/Healthwatch blog (3/29) Email this Story
  Tobacco 
  • FDA drafts rules on tobacco marketing
    The FDA proposed two rules as part of its broader tobacco regulation. The first requires manufacturers to report the amount of harmful compounds in tobacco, while the other calls for scientific evidence to support marketing approval for a "modified-risk" product. Reuters (3/30) Email this Story
  Hot Topics 

Top five news stories selected by FDLI SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  FDLI Items 
  • Annual Conference hotel cut-off is Wednesday -- register and book now
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    • Network: Interact shoulder-to-shoulder with FDA staff; in addition to hundreds of other professionals in the food and drug law community.
    • Engage in hot topic sessions: Regulatory Science; Global Developments and Emerging Markets; Economic, Legal and Regulatory Challenges of Innovation; Social Media and Mobile Apps.
    Agenda, speakers and all conference details are online. Book your accommodations. Email this Story
  • theLINK: A Comprehensive FDA Directory -- 24 Days Left of Free Trial
      
    FDLI's FDA directory, theLINK, is a comprehensive directory of FDA employees and select employees of other agencies including USDA, FTC, CMS, CDC and AHRQ. Its unique functionality makes it a must-have, go-to resource for companies, law firms, libraries and every food and drug law professional. theLINK is continuously updated, well organized, accessible in print and online, and has detailed information on the roles and duties of employees and offices. Enjoy a complimentary trial of the online version through April 26. Learn more and save up to $250 on your new subscription. Email this Story
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Position TitleCompany NameLocation
Regulatory AttorneyConfidentialNJ, NJ
Senior Counsel - Regulatory and Quality Assurance ComplianceProcter & GambleCincinnati, OH
Regulatory Affairs ManagerPrestige BrandsIrvington, NY
Senior and Principal P/T ConsultantsBecker & Associates ConsultingNationwide, United States
Corporate Counsel/Senior Corporate CounselGenentechSouth San Francisco, CA
Manager/Senior Manager, FDAAvalere HealthWashington, DC
CounselVerto Solutions, LLCWashington DC, DC
Manager/Associate Director US Regulatory AffairsPfizerMadison, NJ
Click here to view more job listings.

  SmartQuote 
There is absolutely no inevitability as long as there is a willingness to contemplate what is happening."
--Marshall McLuhan,
Canadian educator, philosopher and scholar


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